Questions
and Answers on Using Over-the-Counter (OTC) Human Drug Products
Containing Analgesic/Antipyretic Active Ingredients Safely
1. What is the Food and Drug Administration (FDA)
announcing today?
The Agency is announcing today:
-
A national consumer
education campaign to help consumers understand how to safely use
OTC pain relievers (analgesics) and fever reducers (antipyretics).
-
The important
educational role healthcare professionals can play in educating
consumers in the safe use of these products.
2. What prompted this campaign?
In September 2002 FDA’s Non-Prescription Advisory
Committee (NDAC) held a public meeting to review the safety and
labeling of certain OTC drug products such as acetaminophen,
aspirin, and nonsteroidal anti-inflammatory drug (NSAIDs).
Specifically, the committee reviewed cases of severe liver injury
associated with the use of acetaminophen. They also reviewed cases
of stomach bleeding and kidney injury related to the use of aspirin
and NSAIDs. The committee recommended changes to the labels of these
products to better inform consumers about the ingredients in the
products and possible serious side effects with improper use. NDAC
also recommended that FDA take a more active role in the education
of consumers and health providers about the safe use of these
products.
3. How do consumers take these medications safely?
You can take these medications safely by carefully reading the directions and by
understanding what drugs are in the products you take. People can
take too much acetaminophen either by not following directions or by
taking products at the same time that both contain acetaminophen. Be
sure and read the directions.
For NSAIDs, carefully read the label and make sure
you do not have a health condition that would increase your risk.
Aspirin and other NSAIDs can cause stomach bleeding. Although it is
rare for these events to occur when using OTC doses and for short
periods of time, some people do develop bleeding. You have an increased risk
if you:
-
have a
previous history of stomach bleeding,
-
are over the age of 60,
-
drink three
or
more alcoholic drinks a day,
-
take steroid medications, or take other NSAID medications.
4. What does
NSAID mean?
Nonsteroidal anti-inflammatory drugs are often
referred to as NSAIDs. This is a group of drugs that include
products such as ibuprofen, naproxen and aspirin. NSAIDs are taken
to reduce minor aches and pains, headaches and fevers.
5. Are these
pain relievers safe to use?
Pain reliever and fever reducer drug products have
been available for many years without a prescription. These products
are safe and effective when used by consumers properly. The FDA
believes that consumers need to know that pain relievers or fever
reducers can cause serious side effects when used improperly. FDA
urges people to read the labels of all the OTC medicines they take
to know how to take them properly.
6. Where can
I find more information on this?
You can find out more information by reading the FDA
Consumer article "Use
Caution with Pain Relievers". You can also ask your pharmacist
or healthcare provider if you have questions about using OTC
medicines with your prescription medicines.
If you have further questions regarding any
medications, please contact the Center for Drug's Division of Drug
Information at: 888-INFO.FDA (888-463-6332), or email us at:
druginfo@fda.hhs.gov.
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Date created: 1/22/2004 |